Operational Checklists

Compliance Checklists.

Execution-ready checklists to reduce avoidable compliance errors and improve internal handoffs.

6Checklists

5Product Categories

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Interactive Tools

Browse Checklists

Each checklist is linked to an interactive tool that validates your compliance readiness in real time.

General

U.S. Agent Onboarding Checklist

Step-by-step onboarding checklist covering appointment letters, FDA system access, and initial communications setup.

~10 minLaunch Tool

Cosmetics

MoCRA Submission Readiness

Verify your cosmetic facility registration and product listing submissions are complete before filing with FDA.

~15 minLaunch Tool

Food

FSVP Evidence Checklist

Ensure your Foreign Supplier Verification Program documentation is audit-ready with complete evidence files.

~20 minLaunch Tool

Drugs

Drug Listing SPL Checklist

Validate your Structured Product Labeling XML files and drug listing data before submission to FDA systems.

~12 minLaunch Tool

Devices

UDI/GUDID Submission Checklist

Confirm your Unique Device Identification data is complete and formatted correctly for GUDID database submission.

~15 minLaunch Tool

Import

Detention Response (First 48 Hours)

Critical action checklist for the first 48 hours after receiving an FDA detention notice on your shipment.

~8 minLaunch Tool

Workflow

How to Use Checklists

Three steps from selecting a checklist to generating your compliance report.

Step 1

Choose Your Checklist

Select the checklist matching your compliance workflow. Each is mapped to a specific FDA requirement.

Step 2

Run the Interactive Tool

Work through the checklist in our interactive tool. Get real-time validation and guidance on each item.

Step 3

Export Your Results

Download a compliance-ready report to share with your team, auditors, or regulatory contacts.

Related Resources

Explore more compliance tools and templates.

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